QRXPY Adcom date set. RMTI submits NDA. ARIA and CYTR initiate pivotal trials.

Mar 25, 2014 No Comments by

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced that the FDA has set 22 April 2014 as the date of the Advisory Committee meeting to consider the resubmitted Moxduo New Drug Application (NDA). The PDUFA date is 25 May, 2014. Rockwell Medical, Inc. (Nasdaq:RMTI)  announced the submission of a New Drug Application (NDA) to the FDA for Triferic (soluble […]

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VNDA FDA Approval. IMGN Phase 3 data release update. RGDO and MELA private placements + CYTR prices offering

Feb 02, 2014 No Comments by

Vanda Pharmaceuticals Inc.(VANDA) (NASDAQ: VNDA) announced that the FDA has approved HETLIOZ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).  HETLIOZ is the first FDA approved medication for Non-24. Regado Biosciences, Inc. (Nasdaq: RGDO) announced that it will sell $20 million of its common stock in a private placement. They also noted that the second interim analysis of REGULATE-PCI […]

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AVNR files NDA. AVEO discontinues BATON trial. CORT date due 2Q. CYTR offering. SLXP PDUFA set + AERI GERN

Jan 31, 2014 No Comments by

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that they have submitted a New Drug Application (NDA) to the FDA for AVP-825, for the acute treatment of migraine. AVEO Oncology (NASDAQ: AVEO $1.67)  announced that AVEO and Astellas Pharma Inc. have jointly decided to discontinue the BATON (Biomarker Assessment of Tivozanib in ONcology) breast cancer Phase 2 trial due to insufficient enrollment. Aerie Pharmaceuticals, Inc. (NASDAQ:AERI $17.91) announced dosing […]

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BDSI ENDP Phase 3 endpoint met. PGNX ATOS TXNP DSCI to raise cash. EXEL XNPT price offerings. APPA NASDAQ uplist + CYTR

Jan 24, 2014 No Comments

Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) filed a $150m shelf and also noted that it has entered into a sales agreement where up to $50m of common stock may be issued and sold under a sales agreement with Cantor Fitzgerald & Co. Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) announced that it intends to offer shares of its common stock in an […]

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CHTP wins at Adcom + updates for MEIP MNOV BMRN CYTR NKTR CTIC NYMX

Jan 15, 2014 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $2.30) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic […]

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OREX refiles Contrave NDA. QRXPY PDUFA date set. CYTR positive STS data + AZN BMY SYN news

Dec 12, 2013 No Comments

Orexigen Therapeutics, Inc. (Nasdaq: OREX $5.56) announced that they have resubmitted the Contrave New Drug Application (NDA), for weight loss and maintenance of weight loss. QRxPharma Limited (ASX: QRX and OTCQX: QRXPY $2.84 ) announced that the FDA has set a PDUFA date of 25 May 2014 for their refiled NDA for immediate release MOXDUO. CytRx Corporation (NASDAQ: CYTR) announced […]

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CYTR data due Wednesday. AVNR fails Phase 2 PRIME trial. SPPI files Belinostat NDA + VICL NWBO news

Dec 10, 2013 No Comments

CytRx Corporation (NASDAQ: CYTR $2.39) announced that it will issue a news release at 8:00 a.m. Eastern time on Wednesday December 11 2013, announcing top-line results from their Phase 2b trial of aldoxorubicin as a first-line treatment for advanced soft tissue sarcomas (STS). They will host a conference call beginning at 10:30 a.m. EST. Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR $4.29) […]

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Offering news for AEZS APPA CSII NWBO +CYTR FOLD news

Nov 21, 2013 No Comments

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.05) priced their public offering of 13.1 million units, with each unit consisting of one common share and one whole warrant to purchase one common share, at a purchase price of US$1.15 per unit. Net proceeds are expected to be approximately $13.7 million. CytRx Corporation (NASDAQ: CYTR $2.15) announced initiation of […]

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Oct 29, 2013 No Comments

The following companies released pipeline updates with their 3Q financial results on Tuesday. Summary as follows: CytRx Corporation (NASDAQ: CYTR) $2.52 4Q13 – initiate a Phase 2 trial with aldoxorubicin in patients with relapsed glioblastoma. 4Q13 – initiate a Phase 2 trial of aldoxorubicin in treating AIDS-related Kaposi’s sarcoma. December 2013 – report top-line progression-free survival results […]

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Aug 07, 2013 No Comments

Vanda Pharmaceuticals Inc.(Vanda) (NASDAQ: VNDA$11.14) announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL $4.14) provided an update that it expects announce a decision about its future plans for fostamatanib in 3Q 2013, as well as Phase 2 data of R343 in allergic asthma. Phase […]

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CTIC Tosedostat placed on partial clinical hold. CYTK reverse split. CYTR aldoxorubicin data due 2H 2013 + PBMD ANTH updates

Jun 25, 2013 No Comments

Cell Therapeutics, Inc. (NASDAQ:CTIC) was informed by the FDA that a partial clinical hold has been placed on Tosedostat, for the treatment of blood-related cancers. This follows the death of a patient from myocarditis. The FDA has requested additional data on patients treated with Tosedostat, including additional information about the patient that died. These data will […]

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